CASE FOR DOCUMENTATION: Dr Gerd Glaeske, a pharmacologist and
health scientist at the University of Bremen, emphasises the importance
of documenting any side effects during therapy with a biologic drug.
Patients should be candid about them with their doctor, he says. (Right)
STILL DEVELOPING: Biologic drugs have been around for just 20 years or
so and now number about 180, according to Dr Gerd Bendas from the
Institute for Pharmaceutical Biology at the University of Bonn in
Germany.

By Elena Zelle

EFFECTIVE: Biologics are a new class of drug that are genetically
engineered inside living cells. The most important of them, therapeutic
antibodies, can be targeted much more precisely than conventional,
chemical medicines. They are genetically engineered inside living cells
and are far more precise at treating people with conditions like
rheumatism or diabetes. A rapidly growing class of drugs is
revolutionising the treatment of illnesses as varied as rheumatoid
arthritis, diabetes and cancer. Known as biologics, they're
genetically engineered inside living cells. The most important of them,
therapeutic antibodies, can be targeted much more precisely than
conventional, chemical medicines. On the minus side, they're much
more expensive than traditional drugs, and they have side effects.
Biologic drugs have been around for just 20 years or so and now number
about 180, according to Dr Gerd Bendas from the Institute for
Pharmaceutical Biology at the University of Bonn in Germany. Before a
synthetic form of insulin was developed for diabetics, the blood
sugar-regulating hormone was extracted from the pancreases of animals
and then purified, he says. In contrast, biologic insulin can be
produced, for example, by a yeast cell into which a human gene sequence,
coded for construction of the insulin protein, has been inserted. Even
more innovative than biologics that replace proteins the body naturally
produces are genetically engineered therapeutic antibodies. They're
able to bind to, and thereby inhibit, specific structures in the body.
In the case of an autoimmune disorder such as rheumatism, this means -
put simply - that rather than broadly disabling the immune system, they
target only particular components of the system such as messenger
molecules that fuel inflammation. Depending on the type of biologic,
rheumatism sufferers inject themselves with the drug at intervals of one
to four weeks, says Dr Stefan Schewe, executive board member of the
German Rheumatism Organization. Some biologic drugs are given by
infusion every eight weeks. Meanwhile, patients continue to take their
previous medicines - traditional disease-modifying antirheumatic drugs
(DMARDs). There are two reasons for this. In the case of rheumatoid
arthritis, for example, DMARDs magnify the effect of the biologic drug,
explains Schewe, adding that "they also prevent the formation of
antibodies against the biologic" since it's a protein the body
will normally identify as foreign and therefore defend itself against.
"If something has an effect, it can also have side effects,"
Bendas says. Among the undesirable side effects is greater
susceptibility to infections. Allergic reactions or intolerances are
possible as well. Nevertheless, Schewe says, "biologics have
certainly brought substantial improvement in therapy for inflammatory
rheumatoid diseases." Before taking a biologic drug, patients have
to be inoculated against pneumococcal pneumonia, a type of bacterial
pneumonia. And certain diseases such as tuberculosis should be ruled out
before therapy starts. Dr Gerd Glaeske, a pharmacologist and health
scientist at the University of Bremen, emphasises the importance of
documenting any side effects during therapy with a biologic drug.
Patients should be candid about them with their doctor, he says. Despite
the benefits of biologics, nowhere near all potential recipients are
given one. They're used for rheumatism only when DMARD therapy
proves to be inadequate, Schewe says, pointing out that the high price
is due to their complex manufacturing process - biologics are between 10
and 100 per cent more expensive than DMARDs - is the biggest obstacle to
wider use. Glaeske puts costs at between 50,000 and 100,000 euros (about
59,000 to 118,000 US dollars) per patient per year. Generic biologics,
also known as biosimilars, are equal to the original drugs in quality
and about 20 to 30 per cent cheaper, Glaeske says. They have the same
effect but may have a different structure and must go through clinical
trials of their own before approval for use. Patients that don't
tolerate a biologic may have no problem with its biosimilar and vice
versa. The first biosimilar hit the market in 2006, according to Bendas.
But generic biologic drugs didn't become an economic factor until
2015, when biosimilars were developed for use against inflammatory
diseases affecting many thousands of people. Bendas says about 600 new
biologicals and biosimilars are in the pipeline at the moment. - DPA